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TerminatedNCT01890083Updated Dec 29, 2016

A Health Intervention to Prevent Depression Hepatitis C Patients

A Phase 2/3 interventional study of Exercise and Health Education in Hepatitis C and Major Depressive Disorder, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-12-29.

Sponsored by University of Texas Southwestern Medical Center · Phase 2/3, Interventional, and Prevention

Why this study was terminated
Lack of eligible patients due to introduction of new drugs for Hepatitis C
Phase
Phase 2/3
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Interferon-alpha (IFN-α) is an efficacious treatment for Hepatitis C (HPC); however, IFN-α treatment results in a significant increase in depressive symptoms. The aim of this project is to compare two health interventions (exercise vs. health education) to prevent depression in HPC patients receiving IFN-α. Participants will be recruited from the Clinical Center for Liver Diseases at UT-Southwestern and randomized to 26 weeks of either: aerobic exercise or a health education control group.

02

Conditions studied

  • Hepatitis C
  • Major Depressive Disorder

Keywords

  • Hepatitis C
  • Interferon-alpha
  • Depression
  • Major Depressive Disorder
  • Exercise
  • Physical Activity
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 1 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with Hepatitis C and prescribed IFN-α
  • Ability to understand and willingness to provide written informed consent.
  • Willing to provide contact information.
  • Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
  • Able to comprehend and communicate in English.

Exclusion criteria

Exclusion Criteria:

  • Have a medical condition contraindicating exercise participation
  • Are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
  • Have been diagnosed with current Major Depressive Disorder or are currently receiving antidepressant medication treatment (including SSRIs and SNRIs)
  • Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
  • Pregnancy.
  • Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
  • Anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the PI or designee.
  • Any reason not listed herein yet, determined by the PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the PI, medical personnel, or designee make participation in the study hazardous.
  • Are currently enrolled in another research study, and participation in that study contraindicates participation in the current study
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1 participant (actual)

Study arms

  • Active comparator
    Health Education

    Participants will three attend heath education sessions per week for 26 weeks.

    Behavioral: Health Education

  • Experimental
    Exercise

    Participants will engage in a public health dose of moderate-to-vigorous aerobic exercise for 26 weeks.

    Behavioral: Exercise

Interventions

  • BehavioralExercise
  • BehavioralHealth Education
06

What researchers measure

Primary outcomes

  1. Change in Depressive Symptoms over 6 months

    Time frame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27

Secondary outcomes

  1. Change in Sleep Quality over 6 months

    Time frame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27

  2. Change in blood biomarkers over 6 months

    Time frame: Baseline, Weeks 3, 5, 7, 11, 15, 19, 23, 27

07

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390-9119, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01890083
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Sponsor
First posted
Jul 1, 2013
Start date
Jun 2013
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Dec 29, 2016

Study contacts

Chad D Rethorst, Ph.D.
principal investigator · UT Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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